Login to Access Video or Poster Abstract: MP31-01
Sources of Funding: Allergan plc and Serenity Pharmaceuticals LLC

Introduction

Two randomized, placebo-controlled phase 3 trials (DB3 and DB4) demonstrated the efficacy/safety of SER120 1.5 mcg, a very low-dose desmopressin nasal spray formulation in patients with nocturia. An open-label extension (OLE) trial of the DB3 study examined the long-term safety and efficacy of SER120 1.5 mcg over a 2-year period.

Methods

The DB3 study enrolled patients ≥50 years of age with ≥2 nocturic episodes/night for at least 6 months. Patients could enroll in the OLE study and receive treatment with SER120 at a lower dose and escalate to the 1.5 mcg dose for up to 126 weeks if they (1) completed the DB3 study or (2) did not participate in the DB3 study but met the DB3 study screening criteria. Patients returned for study visits every 2-8 weeks for assessments. Safety and efficacy assessments were conducted in the intent-to-treat (ITT) population (N=393) and included the incidence of low serum sodium levels, mean serum sodium levels, adverse events (AEs), duration of treatment exposure, and mean change from baseline in nocturic episodes/night.

Results

Of the 393 patients in the ITT population, 358 received the SER120 1.5 mcg dose. At baseline, mean age was 65.7 years, and mean nocturic episodes/night was 3.3. A total of 217, 129, and 42 patients, respectively, had at least 12 months, 18 months and 24 months of exposure to the SER120 1.5 mcg dose. Significant decreases from baseline were observed in the mean nocturic episodes/night as early as week 2 (-1.3), which were sustained up to week 54 (-1.9), week 78 (-1.9), and week 110 (-2.0) (P<.0001 for all timepoints). During the 2-year treatment period, the most commonly reported AEs were nasal discomfort (24.9%), sneezing (10.2%), and rhinorrhea (9.9%), which were mostly mild or moderate in intensity. The mean serum sodium concentration at baseline was 139.7 mmol/L and remained within the normal limits over the entire treatment period. None of the patients reported hyponatremia (serum sodium levels ≤125 mmol/L) at the SER120 1.5 mcg dose for the duration of the study.

Conclusions

SER120 1.5 mcg was well tolerated over the long-term, with no new safety signals observed during the OLE period. A total of 217 patients reached at least 1 year of exposure with the SER120 1.5 mcg dose. Long-term treatment with SER120 1.5 mcg resulted in significant and durable improvements in nocturic episodes/night which were sustained over 2 years.

Funding

Allergan plc and Serenity Pharmaceuticals LLC